ID

38754

Description

The Effects of LY2409021 on the Liver; ODM derived from: https://clinicaltrials.gov/show/NCT01588366

Link

https://clinicaltrials.gov/show/NCT01588366

Keywords

Versions (1)
  1. 10/31/19 10/31/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

October 31, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Diabetes Mellitus, Type 2 NCT01588366

English

Eligibility Diabetes Mellitus, Type 2 NCT01588366

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
for all participants:
Description

Study Subject All

Data type

boolean

Alias
UMLS CUI [1,1]
C0681850
UMLS CUI [1,2]
C0444868
must be a male, or a female who cannot become pregnant, and who is either a healthy participant, or who has type 2 diabetes
Description

Gender | Gender Infertility | Gender Healthy | Gender Non-Insulin-Dependent Diabetes Mellitus

Data type

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2,1]
C0079399
UMLS CUI [2,2]
C0021359
UMLS CUI [3,1]
C0079399
UMLS CUI [3,2]
C3898900
UMLS CUI [4,1]
C0079399
UMLS CUI [4,2]
C0011860
must have a body mass index (bmi) of 18.5 to 29.9 kilograms per square meter (kg/m^2) if a healthy participant, or a bmi of 18.5 to 35.0 kg/m^2 if diabetic
Description

Body mass index | Healthy | Diabetic

Data type

boolean

Alias
UMLS CUI [1]
C1305855
UMLS CUI [2]
C3898900
UMLS CUI [3]
C0241863
for participants with type 2 diabetes mellitus (t2dm):
Description

Study Subject Non-Insulin-Dependent Diabetes Mellitus

Data type

boolean

Alias
UMLS CUI [1,1]
C0681850
UMLS CUI [1,2]
C0011860
on diet and exercise treatment, or taking metformin
Description

Diet therapy | Exercise | Metformin

Data type

boolean

Alias
UMLS CUI [1]
C0012159
UMLS CUI [2]
C0015259
UMLS CUI [3]
C0025598
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
for all participants:
Description

Study Subject All

Data type

boolean

Alias
UMLS CUI [1,1]
C0681850
UMLS CUI [1,2]
C0444868
have signs or symptoms of liver disease
Description

Sign or Symptom Liver disease

Data type

boolean

Alias
UMLS CUI [1,1]
C3540840
UMLS CUI [1,2]
C0023895
are infected with hepatitis b or hepatitis c
Description

Hepatitis B | Hepatitis C

Data type

boolean

Alias
UMLS CUI [1]
C0019163
UMLS CUI [2]
C0019196
have donated more than 450 ml of blood in the last 3 months or if have donated any blood in the last month
Description

Blood Donation Quantity Timespan | Blood Donation Recent

Data type

boolean

Alias
UMLS CUI [1,1]
C0005794
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0872291
UMLS CUI [2,1]
C0005794
UMLS CUI [2,2]
C0332185
smoke more than 10 cigarettes per day or are not willing to abstain from smoking while at the clinic
Description

Tobacco use Number of cigarettes per day | Refrain from Smoking Unwilling

Data type

boolean

Alias
UMLS CUI [1,1]
C0543414
UMLS CUI [1,2]
C3694146
UMLS CUI [2,1]
C4086797
UMLS CUI [2,2]
C0558080
have had surgery with metallic clips, staples or stents, or have had a cardiac pacemaker (or other surgical implants) inserted in any part of the body, or have fear of enclosed spaces or have symptoms that prevent them from being sent for an magnetic resonance imaging (mri) scan
Description

Surgery Clip Metallic | Surgery Staple | Surgery Stents | Pacemaker implant | Implants | Claustrophobia | Symptoms Preventing MRI scan

Data type

boolean

Alias
UMLS CUI [1,1]
C0543467
UMLS CUI [1,2]
C0175722
UMLS CUI [1,3]
C2986473
UMLS CUI [2,1]
C0543467
UMLS CUI [2,2]
C0524724
UMLS CUI [3,1]
C0543467
UMLS CUI [3,2]
C0038257
UMLS CUI [4]
C0848753
UMLS CUI [5]
C0021102
UMLS CUI [6]
C0008909
UMLS CUI [7,1]
C1457887
UMLS CUI [7,2]
C1292733
UMLS CUI [7,3]
C0024485
for participants with t2dm:
Description

Study Subject Non-Insulin-Dependent Diabetes Mellitus

Data type

boolean

Alias
UMLS CUI [1,1]
C0681850
UMLS CUI [1,2]
C0011860
are using insulin
Description

Insulin use

Data type

boolean

Alias
UMLS CUI [1]
C0240016
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Similar models

Eligibility Diabetes Mellitus, Type 2 NCT01588366

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Study Subject All
Item
for all participants:
boolean
C0681850 (UMLS CUI [1,1])
C0444868 (UMLS CUI [1,2])
Gender | Gender Infertility | Gender Healthy | Gender Non-Insulin-Dependent Diabetes Mellitus
Item
must be a male, or a female who cannot become pregnant, and who is either a healthy participant, or who has type 2 diabetes
boolean
C0079399 (UMLS CUI [1])
C0079399 (UMLS CUI [2,1])
C0021359 (UMLS CUI [2,2])
C0079399 (UMLS CUI [3,1])
C3898900 (UMLS CUI [3,2])
C0079399 (UMLS CUI [4,1])
C0011860 (UMLS CUI [4,2])
Body mass index | Healthy | Diabetic
Item
must have a body mass index (bmi) of 18.5 to 29.9 kilograms per square meter (kg/m^2) if a healthy participant, or a bmi of 18.5 to 35.0 kg/m^2 if diabetic
boolean
C1305855 (UMLS CUI [1])
C3898900 (UMLS CUI [2])
C0241863 (UMLS CUI [3])
Study Subject Non-Insulin-Dependent Diabetes Mellitus
Item
for participants with type 2 diabetes mellitus (t2dm):
boolean
C0681850 (UMLS CUI [1,1])
C0011860 (UMLS CUI [1,2])
Diet therapy | Exercise | Metformin
Item
on diet and exercise treatment, or taking metformin
boolean
C0012159 (UMLS CUI [1])
C0015259 (UMLS CUI [2])
C0025598 (UMLS CUI [3])
Item Group
C0680251 (UMLS CUI)
Study Subject All
Item
for all participants:
boolean
C0681850 (UMLS CUI [1,1])
C0444868 (UMLS CUI [1,2])
Sign or Symptom Liver disease
Item
have signs or symptoms of liver disease
boolean
C3540840 (UMLS CUI [1,1])
C0023895 (UMLS CUI [1,2])
Hepatitis B | Hepatitis C
Item
are infected with hepatitis b or hepatitis c
boolean
C0019163 (UMLS CUI [1])
C0019196 (UMLS CUI [2])
Blood Donation Quantity Timespan | Blood Donation Recent
Item
have donated more than 450 ml of blood in the last 3 months or if have donated any blood in the last month
boolean
C0005794 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0872291 (UMLS CUI [1,3])
C0005794 (UMLS CUI [2,1])
C0332185 (UMLS CUI [2,2])
Tobacco use Number of cigarettes per day | Refrain from Smoking Unwilling
Item
smoke more than 10 cigarettes per day or are not willing to abstain from smoking while at the clinic
boolean
C0543414 (UMLS CUI [1,1])
C3694146 (UMLS CUI [1,2])
C4086797 (UMLS CUI [2,1])
C0558080 (UMLS CUI [2,2])
Surgery Clip Metallic | Surgery Staple | Surgery Stents | Pacemaker implant | Implants | Claustrophobia | Symptoms Preventing MRI scan
Item
have had surgery with metallic clips, staples or stents, or have had a cardiac pacemaker (or other surgical implants) inserted in any part of the body, or have fear of enclosed spaces or have symptoms that prevent them from being sent for an magnetic resonance imaging (mri) scan
boolean
C0543467 (UMLS CUI [1,1])
C0175722 (UMLS CUI [1,2])
C2986473 (UMLS CUI [1,3])
C0543467 (UMLS CUI [2,1])
C0524724 (UMLS CUI [2,2])
C0543467 (UMLS CUI [3,1])
C0038257 (UMLS CUI [3,2])
C0848753 (UMLS CUI [4])
C0021102 (UMLS CUI [5])
C0008909 (UMLS CUI [6])
C1457887 (UMLS CUI [7,1])
C1292733 (UMLS CUI [7,2])
C0024485 (UMLS CUI [7,3])
Study Subject Non-Insulin-Dependent Diabetes Mellitus
Item
for participants with t2dm:
boolean
C0681850 (UMLS CUI [1,1])
C0011860 (UMLS CUI [1,2])
Insulin use
Item
are using insulin
boolean
C0240016 (UMLS CUI [1])
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